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Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770337
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Neuroelectrics Corporation

Brief Summary:
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Focal Seizure Seizures, Focal Seizures Epilepsy in Children Epilepsy Epilepsy, Tonic-Clonic Device: STARSTIM device Device: Sham Device Not Applicable

Detailed Description:
Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age, diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for each subject prior to treatment. Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment. Treatment will be done daily at the investigator's site for 10 days. A Seizure Diary will be maintained through the course of the treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board will be utilized to evaluate safety events through study milestones. Seizure frequency rates pre, during and post treatment will be evaluated for both the active and sham treatment arms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multiple site, randomized, double blinded parallel-group controlled study
Masking: Double (Participant, Investigator)
Masking Description: Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment.
Primary Purpose: Treatment
Official Title: STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Sham Comparator: Sham treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Device: Sham Device
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp

Experimental: STARSTIM device treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
Device: STARSTIM device
Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.




Primary Outcome Measures :
  1. The difference between active treatment and sham treatment in the percentage change [ Time Frame: from baseline in seizures over the 12 weeks following initiation of treatment. ]

Secondary Outcome Measures :
  1. The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency [ Time Frame: from baseline to week 12 post-treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 9 years old or older
  2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.

    Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.

  3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
  4. Seizure frequency ≥3 per month, over the past year.
  5. Currently on ≥1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary.
  6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure.
  7. Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri).
  8. Available seizure history and supporting data
  9. All female study subjects of child-bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).
  10. Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study.
  11. Assent from pediatric subjects when appropriate.

Exclusion Criteria:

  1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data.
  2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise , as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the subject's seizures.
  3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
  4. Seizure focus is hemispheric or poorly defined
  5. History of psychogenic nonepileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures.
  6. Seizures of generalized onset
  7. Status epilepticus in the last 12 months
  8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration
  9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data.
  10. Damaged skin on scalp that may interfere with tDCS stimulation.
  11. Pregnant or unwilling to practice birth control during participation in the study.
  12. Nursing mothers.
  13. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g. switched off) during tDCS stimulation and the VNS device is MR conditional.
  14. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
  15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770337


Contacts
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Contact: Demi Thai, M.D demi.thai@neuroelectrics.com
Contact: Thaïs Baleeiro, PhD +34 93 254 03 66 thais.baleeiro@neuroelectrics.com

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Danilo Vitorovic, M.D       dvitorovic@llu.edu   
Contact: Julie Lacanlale, CRC    (909) 558-2037    JLacanlale@llu.edu   
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Charles Liu, M.D       cliu@usc.edu   
Contact: Joanne Gibbons, CRC    (818) 284-1626    joannegi@med.usc.edu   
United States, Florida
University of Florida Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Katherine Zarroli, M.D       katherine.zarroli@jax.ufl.edu   
Contact: Yasmeen Shabbir, CRC    904-244-9856    yasmeen.shabbir@jax.ufl.edu   
United States, Maryland
LifeBridge Health Recruiting
Baltimore, Maryland, United States, 21215
Contact: Arash Foroughi, M.D       aforough@lifebridgehealth.org   
Contact: Seanne Facho, CRC    410.601.0960    sfacho@lifebridgehealth.org   
United States, Massachusetts
Boston Children's Hospital Comprehensive Epilepsy Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexander Rotenberg, M.D       Alexander.Rotenberg@childrens.harvard.edu   
Contact: Paul MacMullin, CRC    (617) 355-7970    Paul.MacMullin@childrens.harvard.edu   
Beth Israel Deconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mo Shafi, M.D       mshafi@bidmc.harvard.edu   
Contact: Lucia Leblanc Perez, CRC    617-632-8934    lleblan1@bidmc.harvard.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brian Lundstrom, M.D       lundstrom.brian@mayo.edu   
Contact: Carey Huebert, CRC    507-293-1120    Huebert.Carey@mayo.edu   
United States, Missouri
Washington University Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert Hogan, M.D       hoganre@wustl.edu   
Contact: Patty Schaefer, CRC    314-362-7871    patty.schaefer@wustl.edu   
United States, New Jersey
Robert Wood Johnson Medical School (Rutgers) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Stephen Wong, M.D       wongst@rwjms.rutgers.edu   
Contact: Asha Cilly, CRC    732-235-7342    ac1659@rwjms.rutgers.edu   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Trent Tollefson, M.D       Trentton_Tollefson@urmc.rochester.edu   
Contact: Noreen L Connolly, CRC    (585) 275-0589    noreen_connolly@urmc.rochester.edu   
United States, Pennsylvania
University of Pennsylvania (Penn Epilepsy) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mindy Ganguly, M.D       taneeta.ganguly@pennmedicine.upenn.edu   
Contact: Melissa Johnston Esparza, CRC    (215) 662-7227    melissa.johnstonesparza@pennmedicine.upenn.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Abou-Khalil Bassel, M.D       bassel.abou-khalil@vumc.org   
Contact: Melissa Osborn, CRC    615-936-0209    melissa.osborn@vumc.org   
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amir Arain, M.D       Amir.Arain@hsc.utah.edu   
Contact: Laura Beeler, CRC    (801) 585-9266    laura.beeler@hsc.utah.edu   
United States, Washington
UW Valley Medical Center Recruiting
Renton, Washington, United States, 98055
Contact: David Vossler, M.D       david_vossler@valleymed.org   
Contact: Shannon Huffaker, CRC    (425) 690-3503    shannon_huffaker@valleymed.org   
Seattle Children's Hospital, University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Xiuhua Bozarth, M.D       xiuhua.bozarth@seattlechildrens.org   
Contact: Jackie Lee-Eng, CRC    12069872078    jacqueline.lee-eng@seattlechildrens.org   
Sponsors and Collaborators
Neuroelectrics Corporation
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Responsible Party: Neuroelectrics Corporation
ClinicalTrials.gov Identifier: NCT04770337    
Other Study ID Numbers: NE001
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Neuroelectrics Corporation:
Epilepsy
Focal seizure
Seizure
Additional relevant MeSH terms:
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Epilepsy
Seizures
Drug Resistant Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Epilepsy, Tonic-Clonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations